WO2019033989A1

WO2019033989A1 - Cardiac valve prosthesis

Info

Publication number: WO2019033989A1
Application number: PCT/CN2018/099680
Authority: WO
Inventors: 刘明; 阳明; 陈国明; 李�雨
Original assignee: 上海微创心通医疗科技有限公司
Priority date: 2017-08-18
Filing date: 2018-08-09
Publication date: 2019-02-21
Also published as: CN109394393A

Abstract

Disclosed is a cardiac valve prosthesis for replacing a natural valve in a human body. The natural valve comprises a valve ring (6), and the cardiac valve prosthesis comprises an expandable stent body (1), artificial leaflets (2) fixed on the stent body (1), and at least one outwardly protruding structure (3) arranged on a side wall of the stent body (1). After the cardiac valve prosthesis is implanted into the human body, the at least one outwardly protruding structure (3) is arranged above the valve ring (6) to limit the position of the cardiac valve prosthesis. The outwardly protruding structure (3) is arranged above the valve ring (6) to limit the position of the cardiac valve prosthesis. By means of the bottom of the outwardly protruding structure (3) abutting against the top of the valve ring (6) in a expanded form, the cardiac valve prosthesis can be prevented from shifting towards the ventricle, effectively solving the problem of the anchorage of the cardiac valve prosthesis in a released position without causing calcification of a root of the valve, and also achieving the stable implantation of the cardiac valve prosthesis.

Description

Heart valve prosthesis

Technical field

The present invention relates to the field of medical device technology, and in particular to a heart valve prosthesis.

Background technique

Current transcatheter aortic valve replacement (TAVR) is mainly used for the treatment of severe aortic stenosis, while TAVR treatment of aortic regurgitation is under investigation. Aortic regurgitation refers to the flow of blood that has flowed into the aorta back to the left ventricle due to a loosely closed aortic valve during diastole. Mild to moderate aortic regurgitation may have no significant symptoms, and patients with moderate to severe aortic regurgitation may experience a cardiac compensatory period, with an average survival of only 2 to 5 years after loss of compensation.

Most of the existing TAVR valves are fixed by stent self-expansion (represented by Medtronic Core-Valve) or balloon-expandable stent (represented by Edwards Sapien), and the stent is fixed with calcified leaflets and annulus; In patients, after the stent itself expands, the calcified leaflets or annulus can hold the stent firmly, and the fixation is achieved by the calcified tissue and the radial support of the stent. From the anatomical features of aortic regurgitation, the primary valve leaf and the aortic root are often not necessarily accompanied by severe calcification, which is flexible, so the traditional TAVR valve cannot be fixed by radial support force. Although there are some reports based on the use of traditional TAVR valves (radial support force fixation) for aortic regurgitation, the overall effect is not good, the valve is prone to turbulence to the ventricular outflow tract, such as Medtronic Core-Valve , DFM, Lotus. For this reason, TAVR valves for the treatment of aortic regurgitation have become an industry challenge.

In recent years, TAVR treatment for aortic regurgitation has been studied at home and abroad, and some new valves for aortic regurgitation have emerged. For example, Jena Valve and Medtronic Engager use the three clips on the bracket to clamp the native leaflets between the clip and the valve body to achieve valve fixation; J-Valve uses the same concept, except that its clips are The valve body is not integral. All of them use transapical implantation, which has a disadvantage of being traumatic compared with the traditional TAVR valve transfemoral implantation. The Edwards HELIO+XT system is based on the original Edwards Sapien-XT valve prosthesis, adding a rigid clamp (HELIO), the clamp is placed in the aortic sinus, and then the Sapien-XT valve is faked. Body release, clamps and valves clamp the native leaflets for fixation. PCR 2013 reports the treatment of aortic regurgitation by transfemoral implantation of the clamp and transapical implantation of the Sapien-XT valve, and it is expected that the implementation of the insertion of the clamp and the valve through the transfemoral approach in the future. It can be found that such a product system is complicated to operate and has high requirements for the operation of a doctor, and there are obvious deficiencies.

Summary of the invention

It is an object of the present invention to provide a heart valve prosthesis for effective self-fixation when a heart valve prosthesis is used to treat valvular regurgitation, which has a better effect.

It is also an object of the present invention to provide a heart valve prosthesis such that the heart valve prosthesis is less invasive when treating valvular regurgitation and is simple to operate.

In order to solve the above technical problems, the present invention provides a heart valve prosthesis for replacing a native valve in a human body, the native valve comprising an annulus, the heart valve prosthesis comprising an expandable stent a body, a prosthetic leaflet fixed to the stent body, and at least one convex structure arranged on a side wall of the stent body; the at least one convexity when the heart valve prosthesis is placed in a human body A structure is provided over the annulus to limit the position of the heart valve prosthesis.

Optionally, in the heart valve prosthesis, the stent body is a mesh column structure, the mesh column structure comprises a plurality of meshes, the mesh holes are formed by node connections, and the stent body comprises a first An end portion and a second end portion for extending at the annulus after the heart valve prosthesis is placed in a human body, the second end being provided with an auxiliary unit for connecting A delivery component of the prosthetic delivery system.

Optionally, the heart valve prosthesis has a contracted shape and an expanded configuration, and each of the convex structures can be gathered in a corresponding one of the meshes when the heart valve prosthesis is in a contracted configuration. .

Optionally, in the heart valve prosthesis, the number of the convex structures is plural, and each of the convex structures includes at least two first arm structures and the first arm structure. a second arm structure of the same number, one end of each of the first arm structures is connected to the mesh column structure; the other end of each of the first arm structures is connected to a corresponding one of the second arm structures At one end, the other ends of each of the second arm structures in each of the protruding structures are connected to each other.

Optionally, in the heart valve prosthesis, each of the convex structures includes two of the first arm structure and two of the second arm structures, and the first arm structure The junction with the second arm structure and the junction of the two second arm structures are all circular arc shapes.

Optionally, in the heart valve prosthesis, each of the first arm structures extends radially outward relative to the bracket body, and each of the second arm structures is from a corresponding first The other end of the arm structure extends toward the second end of the bracket body.

Optionally, in the heart valve prosthesis, the native valve further comprises a native leaflet, and at least one of the convex structures further comprises a cantilever rod, the cantilever rod from the second arm structure The other end extends toward the first end for piercing the native leaflets.

Optionally, in the heart valve prosthesis, the cantilever rod extends in a direction parallel to an axial direction of the stent body.

Optionally, in the heart valve prosthesis, the angle between the first arm structure and the first direction is 30° to 90°, and the second arm structure and the first direction are The angle between the two is -60° to 60°, the first direction is the direction from the first end to the second end and the first direction is parallel to the axial direction of the bracket body.

Optionally, in the heart valve prosthesis, the distance between the second arm structure and the bracket body is 2 mm to 6 mm.

Optionally, in the heart valve prosthesis, the first arm structure connects the end of the bracket body to the bottom of the first end of the bracket body by a distance of 5 mm to 15 mm.

Optionally, in the heart valve prosthesis, the heart valve prosthesis further comprises a skirt structure, the skirt structure is stitched on the inner side wall of the bracket body, and the artificial leaflet is located near One side of the first end.

Optionally, in the heart valve prosthesis, the material of the stent body is nickel titanium alloy.

Optionally, in the heart valve prosthesis, the bracket body is integrally formed with the at least one protruding structure.

In the heart valve prosthesis provided by the present invention, the position of the heart valve prosthesis is restricted by a convex structure disposed above the annulus, and the deployed shape can be abutted against the annulus under the convex structure. Above, prevent the heart valve prosthesis from agitation, effectively solve the anchoring problem of the heart valve prosthesis in the release position under the condition of no calcification of the root of the native valve, and achieve stable implantation of the heart valve prosthesis. The stent body and the convex structure in the invention are small in volume, and are suitable for various transcatheter implantation such as transfemoral implantation, and the wound is small and the operation is simple.

DRAWINGS

1 is a schematic front elevational view of a heart valve prosthesis according to an embodiment of the present invention;

2 is a schematic top plan view of a heart valve prosthesis according to an embodiment of the present invention;

3 is a schematic front elevational view of a heart valve prosthesis and an aorta according to an embodiment of the present invention;

4 is a top plan view of the heart valve prosthesis and the aorta according to an embodiment of the present invention;

Figure 5 is a schematic front elevational view of a heart valve prosthesis according to another embodiment of the present invention;

6 is a schematic front elevational view of a conical shaped heart valve prosthesis according to another embodiment of the present invention;

7 is a schematic top plan view of a conical shaped heart valve prosthesis according to another embodiment of the present invention;

Figure 8 is a schematic front elevational view of a heart-shaped heart valve prosthesis of another embodiment of the present invention;

9 is a schematic top plan view of a heart-shaped valve prosthesis of a wine glass form according to another embodiment of the present invention;

Figure 10 is a schematic illustration of a heart valve prosthesis assembled in a sheath tube in accordance with another embodiment of the present invention;

The figure shows:

1-stent body; 11-first row node; 12-second row node; 13-third row node; 2-prosthetic leaflet; 3-convex structure; 31-first arm structure; 32-second Boom structure; 33-cantilever rod; 4-skirt structure; 5--prosthetic leaflet; 6-valvular ring; 7-watt sinus; 8-aorta; 9-sheath; 10-auxiliary unit.

Detailed ways

The inventors of the present application have found that the use of a valve fixed solely by radial support force can not achieve good results in the treatment of aortic regurgitation, which is manifested in problems such as instability of anchoring and easy turbulence. Achieve good therapeutic results. The novel valve with the combined leaflet method is used for the treatment of aortic valve regurgitation by the apical method. The wound is large and the operation is complicated. The specific structure is that the structure of the valve leaflet is clamped by the clip. The overall size of the valve is large, and it needs to be adopted. Transapical implantation is more traumatic than conventional TAVR valve transfemoral implantation, which is not conducive to postoperative recovery in elderly patients. The method of implanting the clamp and the valve in a apical manner has a complicated operation and a higher requirement for the doctor, in addition to the traumatic disadvantage of the transfemoral.

Therefore, there is a need in the art for a new heart valve prosthesis to achieve a heart valve prosthesis in the treatment of aortic regurgitation, which can effectively achieve self-fixation of the prosthesis, and is suitable for transcatheter implantation such as transfemoral implantation. Into the surgery, the trauma is small, the operation is simple.

To achieve the above, an embodiment of the present invention provides a heart valve prosthesis for replacing a native valve in a human body, the native valve including an annulus, the heart valve prosthesis including a stent body a prosthetic leaflet fixed to the stent body and a convex structure arranged on the side wall of the stent body; when the heart valve prosthesis is placed into a human body, the convex structure is used for Above the annulus, thereby limiting the position of the heart valve prosthesis, effectively solving the anchoring problem of the interventional prosthetic heart valve prosthesis in the release position without significant calcification at the root of the native valve; With the intervention, the trauma is small, the release of the heart valve prosthesis is simple, and the operation time and the recovery time can be effectively improved.

Of course, it will be understood by those skilled in the art that the heart valve prosthesis proposed in the present invention is applicable not only to the aortic valve but also to the mitral, tricuspid and pulmonary valves.

The heart valve prosthesis of the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. Advantages and features of the present invention will be apparent from the description and appended claims. It should be noted that the drawings are in a very simplified form and both use non-precise proportions, and are only for convenience and clarity to assist the purpose of the embodiments of the present invention.

As shown in Figures 1-3, the present embodiment provides a heart valve prosthesis for replacing a native valve in a human body, for example, instead of a pro-aortic valve located between the aorta and the ventricle, Mitral or tricuspid valve. The primary aortic valve is selected as an example in this embodiment. As shown in FIG. 3, the native valve includes an annulus 6 and a sinus sinus 7 connected to the annulus 6, and the other end of the sinus 7 is connected to the aorta 8 The Valsalva sinus 7 protrudes outward relative to the annulus 6 and the aorta 8. This embodiment will be described in terms of the angle of view of Fig. 3, that hereinafter "upper" or "above" refers to the side closer to the aorta 8, and "lower" or "lower" hereinafter means closer to the annulus One side of 6. The heart valve prosthesis includes a stent body 1 , a prosthetic leaflet 2 fixed to the stent body 1 , and a convex structure 3 arranged on a side wall of the stent body 1 , wherein: the prosthetic leaflet 2 For opening when blood flows from the ventricle to the aorta, and closing when blood flows from the aorta to the ventricle; when the heart valve prosthesis is placed into the human body, the convex structure 3 is used to abut the annulus Above the sixth, thereby limiting the position of the heart valve prosthesis, as shown in Figure 3, the convex structure 3 extends radially relative to the stent body until all or part of the Valsal is placed above the annulus 6 In the space formed by the sinus 7, the lower edge of the convex structure 3 can be attached to the lower wall of the sinus 7 or the aortic annulus 6, and the stent is given by the support of the lower wall of the sinus 7 or the aortic annulus 6 The body 1 has a supporting function to prevent the stent body 1 from swaying downward and realize the fixation of the valve prosthesis. It will be understood by those skilled in the art that if the valvular or tricuspid valve is replaced by the heart valve prosthesis, the petal-like structure is above the annulus, and although there is no Valsalva, the convex structure 3 can be accommodated. Within the petal structure and against the annulus, thereby limiting the position of the heart valve prosthesis.

In the heart valve prosthesis provided in this embodiment, the position of the heart valve prosthesis is restricted by the convex structure 3 abutting above the annulus, that is, the convex structure is used for relative to the stent body Radially extending until it is caught in the space formed by the sinus sinus 7, when the blood flows back from the aorta 8 to the ventricle, the artificial leaflet 2 is closed, and the convex structure 3 can be responsive to the lower side of the convex structure 3 in the deployed configuration. Relying on the annulus 6 to counteract the pressure of the blood returning to the ventricle on the prosthetic leaflet 2, preventing the heart valve prosthesis from pulsing to the ventricle, effectively solving the condition of the aortic valve root without calcification, the heart valve prosthesis in the release position Anchoring problem to achieve stable implantation of heart valve prosthesis. When the heart valve prosthesis is not released, the stent body and the convex structure 3 are compressed and gathered, and the convex structure is accommodated in the gap of the adjacent mesh unit, and the extra volume occupied in the sheath of the delivery prosthesis is small, and is applicable. A variety of transcatheter implantations such as transfemoral implantation have small trauma and simple operation.

As shown in FIG. 3 to FIG. 4, the bracket body 1 is a mesh column structure formed by connecting a plurality of bracket rods, and the mesh column structure includes a plurality of mesh holes, and the mesh holes are surrounded by the bracket rods, and the bracket rods are arranged. The connection point between them is defined as a node of a mesh column structure, and the mesh hole is formed by a node connection, the bracket body includes a first end portion and a second end portion, and the first end portion is used for propping up On the annulus 6, a radial support force is provided, and the second end is provided with an auxiliary unit 10 for connecting the delivery sheath of the implant delivery system (see part 9 in Fig. 10). Preferably, each node of the mesh column structure is arranged in a plurality of rows, and the plane of each row of nodes is substantially perpendicular to the axis of the bracket body 1, and the adjacent two rows of nodes are staggered along the circumferential direction of the bracket body 1. Taking the bracket body 1 shown in FIG. 3 as an example, starting from the bottom of the first end of the bracket body 1, the first row of nodes 11, the second row of nodes 12, the third row of nodes 13, ... are sequentially included. The number of rows of nodes included in the stent body 1 is determined by the type of implant and design parameters, and the present invention does not limit this. The size of the mesh is determined by the distance between the nodes. The mesh sizes in the same row are basically the same. The meshes of different rows may have the same size or different sizes, and the number of meshes in different rows may be the same or different. The native valve further includes a native leaflet 5 extending outwardly from the circumferential side of the annulus 6 in the native aortic valve of the present embodiment, the length of the stent body 1 (ie, axial dimension) Greater than the length of the sinus sinus 7, the stent body 1 extends axially from the aortic annulus 6 to the sinus sinus 7 and further axially to the aorta 8, the stent body 1 With elasticity, the native leaflet 5 is squeezed to the side of the sinus sinus 7. The artificial leaflet 2 is fixed to the inner side wall of the stent body 1 for replacing the native leaflet 5.

Specifically, as shown in FIGS. 1 to 10, in the heart valve prosthesis, the number of the convex structures 3 is plural. Referring to a partial enlarged view of FIG. 1, each of the convex structures 3 includes at least two first arm structures 31 and a second arm structure 32 of the same number as the first arm structures 31, each One end of the first arm structure 31 is connected to the mesh column structure, and the other end of each of the first arm structures 31 is connected to one end of the corresponding one of the second arm structures 32, and the same convex structure. The other ends of each of the second arm structures 32 of 3 are connected to each other.

Preferably, the number of the first arm structure 31 and the second arm structure 32 are two, and the connection between the first arm structure 31 and the second arm structure 32 and two The joints of the second arm structures 32 have a circular arc structure to avoid stress concentration and damage the side walls and annulus of the blood vessel. The side projection of the convex structure 3 has an L-shaped structure, as shown in the lower part of FIG. A partially enlarged view, of course, those skilled in the art can understand that the L-shape referred to herein is substantially L-shaped, and the angle between the first arm structure 31 and the second arm structure 32 is not necessarily Right angle, as long as the top of the second arm structure 32 does not penetrate the side wall of the blood vessel, for example, the radial distance between the top and bottom of the second arm structure 32 relative to the bracket body 1 may be substantially the same, or the second arm The top of the rod structure 32 may be closer to the stent body 1 in the radial direction relative to the bottom of the second arm structure 32, or the top of the second arm structure 32 relative to the second arm without penetrating the side walls of the vessel The bottom of the rod structure 32 can also be radially further away from the bracket body 1; the first arm The front projections of the structure 31 and the second arm structure 32 are substantially inverted V-shaped or inverted U-shaped structures, as shown in a partially enlarged view in the upper part of FIG. 1, that is, each of the first arm structures. 31 extending radially outward relative to the bracket body 1 , each of the second arm structures 32 facing the said bracket body 1 at an angle from the other end of the corresponding one of the first arm structures 31 The two ends extend. For the purpose of clear display, the partial stent body on the rear side of the convex structure 3 is not shown in the partial enlarged view.

In addition, in other embodiments, as shown in FIG. 5, at least one of the protruding structures 3 further includes a cantilever rod 33 from the other end of the second arm structure 32, ie, One end of the two-arm structure 32 connected to each other extends toward the first end for piercing the native leaflets 5, preferably, each of the convex structures 3, two or more The nodes connected to the second arm structure 32 extend out of the cantilever rod 33, and the cantilever rod 33 penetrates the native leaflet 5 to achieve dual fixation of the heart valve prosthesis. In FIG. 5, the cantilever The extending direction of the rod 33 may be substantially parallel to the axial direction of the bracket body 1.

Further, a direction from the first end to the second end is defined herein as a first direction, and the first direction is parallel to an axial direction of the bracket body 1, the first The angle between the arm structure 31 and the first direction is 30° to 90°, and the angle between the second arm structure 32 and the first direction is −60° to 60°, that is, the second The arm structure 32 may extend toward the bracket body 1 in a direction in which it is close to the bracket body 1 or may extend away from the bracket body 1. The distance from the second arm structure 32 to the bracket body 1 is 2 mm to 6 mm. The first arm structure 31 is connected to one end of the bracket body 1 to a distance of the bracket body 1 at the bottom of the first end portion of 5 mm to 15 mm. Generally, the number of the convex structures 3 is plural, preferably four, uniformly disposed on the outer peripheral surface of the bracket body 1, and the first arm structure 31 and the bracket body 1 included in all the convex structures 3 are The joints are all located on the same plane in the radial direction. Preferably, the two first arm structures 31 are evenly distributed on the transverse plane of the bracket body 1, more specifically, the first arm structure 31 and the bracket body 1 The third row of nodes 13 are connected. As described above, the third row of nodes refers to the nodes on the same week from the bottom of the first end of the bracket body 1 in the third row. The advantage of attaching the first arm structure 31 to the node is that the convex structure 3 is integrally formed with the stent body 1 to improve the connection reliability and to facilitate the compression and contraction of the heart valve prosthesis to the contracted configuration. It will be readily understood that the first boom structure 31 may also be fixed to the node without being fixed to the node.

The material of the stent body 1 is preferably a nickel-titanium alloy, has a material memory function, and has good elasticity, which can prevent deformation of the stent body 1 caused by blood pressure, and the stent body 1 is integrated with the convex structure 3 Forming, the entire heart valve prosthesis structure is more reliable, and the surface is smooth, no damage to the blood vessels. The artificial leaflet comprises three single leaves, and the three single leaves are, for example, prepared by the anti-calcification treatment of the pig pericardium material, and are fixed on the stent body by suturing or bonding, mainly distributed in the stent. The first end (inflow path) area of the body. As shown in FIG. 1, in the heart valve prosthesis, the heart valve prosthesis further includes a skirt structure 4, the skirt structure 4 is sewn on the inner side wall of the bracket body 1, and is located at the The prosthetic leaflet 2 is adjacent to the side of the first end to prevent leakage of the valve. The prosthetic leaflet 2 is a trilobal valve, and FIG. 2 illustrates its top view. The skirt structure 4 can be prepared from a biocompatible polymer, such as polyethylene terephthalate (PET). It may be a homologous or heterologous biological material preparation.

The stent body 1 further has an auxiliary unit 10 near the second end of the aorta. As shown in FIG. 10, the auxiliary unit 10 is used to guide the stent body 1 with the guide rod 9 in the sheath tube in the stent delivery system. The heart valve prosthesis is delivered to the blood vessel through the femoral artery by a stent delivery system. The stent body 1 is self-expanding and has a contracted configuration for delivery and a deployed configuration for release. The stent delivery system and delivery method thereof are known in the art and are not specifically developed herein.

Further, one end of each of the first arm structures 31 is connected to the node of the mesh column structure, and the node connected to the first arm structure 31 is located larger than the mesh structure 3 is expanded. The contour of the mesh structure adjacent to the convex structure 3 is large, so that the convex structure 3 can be accommodated in the gap of the mesh column structure of the stent body 1 in the contracted configuration of the entire heart valve prosthesis. in. Compared with the heart valve prosthesis in which the convex structure 3 is not provided, the outer shape of the contracted body 1 of the present embodiment is not significantly enlarged, and can be transported to the release position via the femoral artery.

In the present embodiment, the bracket body 1 is shaped into a cylindrical shape (as shown in FIGS. 1 to 5), that is, the radial dimension of the first end to the second end is substantially the same. In other embodiments, the stent body 1 can also be shaped into a conical shape (as shown in FIGS. 6-7), and the stent body is a vertebral body having a taper of 2 to 5 degrees, that is, a radial dimension of the second end portion. Slightly larger than the radial dimension of the first end portion (upper and lower), the form can further prevent the bracket body from swaying upward, thereby achieving effective anchoring of the bracket body, or the bracket body 1 can also be shaped into a wine glass shape (eg 8 to 9), that is, the outflow channel of the stent body (the portion close to the side of the aorta 8) is shaped into a large-diameter petal shape. After the stent body is released, the structure can abut against the ascending aortic vessel wall, which can improve the centering of the stent body and the aortic annulus, and improve the anchoring performance of the stent body.

In all embodiments, the stent body 1 is expandable, having a contracted configuration of delivery and a deployed expanded configuration. The outwardly convex structure 3 can be accommodated in the gap of the mesh unit of the stent body 1 in the contracted state, and the outer shape of the stent body 1 in the contracted form is not significantly enlarged, and can be transported to the release position via the strand. The bracket body 1 is made of nickel-titanium alloy. Preferably, the nickel-titanium superelastic alloy is used, and the deformation is up to 8%, which can be completely reduced, and the blood pressure is prevented from deforming the stent body.

Figure 3 illustrates the anchoring effect of an exemplary valve prosthesis of the present invention at the aortic root. After the valve prosthesis is released from the aortic root, the first end (inflow channel) of the stent body 1 cooperates with the aortic annulus 6, and the aortic annulus is expanded by the radial supporting force of the stent body; the stent body inflow region The second arm structure of the convex structure 3 can squeeze the native leaflets 5, and the valve prosthesis is anchored at the root of the aorta by the radial fixation force and the integrated fixation effect of the convex structure 3, thereby realizing the stable operation of the valve prosthesis. 4 is a top view of the anchoring effect. As can be seen from FIG. 4, after the release of the valve prosthesis, the diameter of the pitch circle formed by the convex structure 3 is much larger than the diameter of the annulus 6, and the convex structure 3 can effectively abut against the lower wall of the V. sinus 7 And the aortic annulus 6 achieves reliable anchoring of the valvular prosthesis.

The convex structure 3 is disposed in a curved shape, and the first arm structure 31 extends from the node of the mesh column structure and is connected to the second arm structure 32 in a straight shape to the outside. The second arm structure 32 is connected. It is arranged to extend toward the second end (outflow path) of the stent body, and the convex structure 3 as a whole is shaped like an outwardly extending petal. The height of the bottom of the first protruding portion of the bracket body 1 is 5-15 mm, which can well adapt to the height of the native leaflet 5, and ensure that the convex structure 3 can be accurately matched to the aortic annulus 6 and tile. The sinus 7 is on the lower wall.

Further, the first arm structure 31 is a straight rod extending from a node of the mesh column structure. Correspondingly, the second arm structure 32 can also be a straight rod, and a corresponding number of second arm structures 32 and The one arm structure 31 is connected, and the other end of the second arm structure 32 intersects.

After the stent body 1 is inflated, the above-mentioned convex structure 3 extends from the main structural unit of the stent body 1. The contour diameter of the convex structure is larger than the contour diameter of the first end portion (inflow channel) of the stent body. Increasingly, preferably, the contour diameter of the convex structure 3 is 4 to 12 mm larger than the diameter of the first end portion (inflow path) of the stent body 1.

In the embodiment of the present invention, the bracket body 1 is made of a nickel-titanium alloy tube, preferably made of a nickel-titanium superelastic tube, and is formed into a developed form by heat treatment, polishing, and the like. Due to the shape memory characteristics of the nickel-titanium alloy, the stent body 1 has a self-expanding property, a contracted form of transport and a released form of release.

In the contracted configuration of the stent body, the convex structure can be accommodated in the gap of the mesh unit, so that the outer shape of the contracted body of the stent body is not significantly enlarged, and can be transported to the release position via the strand. Figure 10 illustrates the contracted configuration of the stent body in a transport state. After the convex structure 3 is compressed and gathered, it is accommodated in the gap of the adjacent grid unit, and the stent body can be properly loaded in the sheath 9 of the delivery system.

The heart valve prosthesis of the present invention can be inserted through the femoral artery and released at the root of the aorta, and the trauma is small compared with the transapical intervention, which can effectively improve the postoperative recovery time. Compared with the release operation of the existing clamping valve, the valve prosthesis of the invention has a one-piece structure, and the valve body can be released only by pulling the sheath tube when the stent body is released, and the operation is simple, and the operation operation can be effectively improved. time.

In summary, the above embodiments describe the different configurations of the heart valve prosthesis in detail. Of course, the present invention includes, but is not limited to, the configurations listed in the above embodiments, and any of the configurations provided by the above embodiments are performed. The contents of the transformation are all within the scope of protection of the present invention. Those skilled in the art can make the same according to the content of the above embodiments.

The various embodiments in the present specification are described in a progressive manner, and each embodiment focuses on differences from other embodiments, and the same similar parts between the various embodiments may be referred to each other. The above description is only for the description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes and modifications made by those skilled in the art in light of the above disclosure are all within the scope of the appended claims.

Claims

A heart valve prosthesis for replacing a native valve in a human body, the native valve comprising an annulus, wherein the heart valve prosthesis comprises an expandable stent body, fixed to the a prosthetic leaflet on the stent body and at least one convex structure arranged on the side wall of the stent body; when the heart valve prosthesis is placed into a human body, the at least one convex structure is used for Above the annulus, thereby limiting the position of the heart valve prosthesis.
The heart valve prosthesis according to claim 1, wherein the stent body is a mesh column structure, the mesh column structure comprises a plurality of meshes, each of the mesh holes being formed by a node connection, the stent The body includes a first end and a second end, the first end being adapted to be open at the annulus after the heart valve prosthesis is placed in a human body, and the second end is provided with an auxiliary unit a transport component for connecting the prosthetic delivery system.
The heart valve prosthesis of claim 2 wherein said heart valve prosthesis has a collapsed configuration and an expanded configuration, each of said convex structures when said heart valve prosthesis is in a collapsed configuration Can be collapsed in a corresponding one of the cells.
The heart valve prosthesis of claim 2, wherein the number of the convex structures is plural, each of the convex structures comprising at least two first arm structures and the first arm a second arm structure having the same number of rod structures, one end of each of the first arm structures is connected to the net column structure; and the other end of each of the first arm structures is connected to a corresponding one of the second arms One end of the rod structure, the other end of each of the second arm structures in each of the protruding structures is connected to each other.
The heart valve prosthesis of claim 4, wherein each of said convex structures comprises two of said first arm structures and two of said second arm structures, and said first arm The joint of the rod structure and the second arm structure and the joint of the two second arm structures are all circular arc shapes.
A heart valve prosthesis according to claim 4 or 5, wherein each of said first arm structures extends radially outwardly relative to said stent body, each of said second arm structures being correspondingly The other end of one of the first arm structures extends toward the second end of the bracket body.
The heart valve prosthesis of claim 4 or 5, wherein the native valve further comprises a native leaflet, at least one of the convex structures further comprising a cantilever rod, the cantilever rod from the second arm The other end of the rod structure extends toward the first end for piercing the native leaflets.
The heart valve prosthesis of claim 7, wherein the cantilevered rod extends in a direction parallel to the axial direction of the stent body.
The heart valve prosthesis according to claim 4 or 5, wherein the angle between the first arm structure and the first direction is 30° to 90°, and the second arm structure and the The angle between the first directions is -60° to 60°, the first direction is a direction from the first end to the second end, and the first direction is an axial direction of the bracket body Parallel.
The heart valve prosthesis according to claim 4, wherein the distance between the second arm structure and the stent body is 2 mm to 6 mm.
The heart valve prosthesis of claim 4, wherein the first arm structure connects the end of the stent body to the bottom of the first end of the stent body by a distance of 5 mm to 15 mm.
The heart valve prosthesis of claim 2, wherein the heart valve prosthesis further comprises a skirt structure stitched to the inner side wall of the stent body and located in the artificial valve The leaf is near the side of the first end.
The heart valve prosthesis of claim 1 wherein the stent body is made of a nickel titanium alloy.
The heart valve prosthesis of claim 1 wherein said stent body is integrally formed with said at least one convex structure.